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A Caregiver-mediated Health Educational Intervention to Improve Constipation Status of Primary School Children

Primary Purpose

Constipation

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Constipation Health Education Intervention Course
General Health Course
Sponsored by
Asia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Constipation focused on measuring constipation, Bristol Stool Scale, health educational intervention

Eligibility Criteria

10 Years - 13 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Children with grades 3~6 in general classes of primary schools and their primary caregivers

Exclusion Criteria:

  • (1) Students who have mild or more server mental disabilities.
  • (2) Suspected children with mild cognitive impairment who are receiving resource class services.
  • (3) Due to congenital structure, endocrine, small intestinal nerve or muscle abnormalities, abdominal muscle tissue, connective tissue abnormalities, neurological abnormalities, such as irritable bowel syndrome, Hirschsprung disease, milk allergy (lactose intolerance), lupus erythematosus School children in other situations.
  • (4) Children with gastrointestinal-related diseases caused by acquired factors such as heavy metals, vitamin D poisoning, drugs, etc.
  • (5) School children with intestinal paralysis or slow transmission problems, such as hypothyroidism, hypokalemia, and anal sphincter damage.

Sites / Locations

  • Yunlin County Shuicanlin Elementary School
  • Raoping Elementary School

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Constipation Health Education

General Health Course

Arm Description

Health education leaflets are distributed once a week, and students are asked to bring it back to their parents to read. The activity of "seeing leaflets, accumulating points, and redeeming prizes" is adopted. a reply slip is designed in the weekly health education content, containing 3-5 test questions. Parents need to complete the answers and sign after reading the health education content. Those who have a high degree of correctness and fully paid in within 4 weeks will receive additional points. Students are required to keep a " Stool diary record sheet " every day, and it will be posted in the contact book. Children who have confirmed records and turned in will get 10 points a week, and those who turned in all 8 weeks without random answers can get extra points. The points of the parent health education receipt and the points of the children will be combined and calculated, and the weight will be set according to the total number of points for the draw.

In order to correctly evaluate the effectiveness of health education intervention, only the parents of the experimental group will receive the health education leaflet during the intervention period. However, after the end of the trial, an electronic file of parental health education in the control group will be provided. Students are required to keep a " Stool diary record sheet " every day, and it will be posted in the contact book. Children who have confirmed records and turned in will get 10 points a week, and those who turned in all 8 weeks without random answers can get extra points. After the children's points are counted, a lottery will be drawn based on the total number of points. Since the experimental group and the control group have different benchmarks for points, the lottery will be drawn separately from each school. During the lottery process, the time will be announced in advance, and the number will be randomly selected by the computer in a live broadcast method.

Outcomes

Primary Outcome Measures

The change of parents' knowledge towards constipation related issues between 0-week and 4-week
The research tool used in this study is a self-compiled scale of knowledge in the questionnaire. There are 15 items in the scale. For each item, the scoring is 1 or 0 depending on whether a participant's answer is correct or incorrect. Thus the score of this scale ranges from 0 to 15. The higher the score, the better the participant's knowledge of constipation.
The change of parents' attitude towards constipation related issues between 0-week and 4-week
The research tool used in this study is a self-compiled scale of attitude in the questionnaire. There are 10 items in the scale. Likert 5-point scale is used for each item, with 1 representing strongly disagree and 5 strongly agree. Thus the score of this scale ranges from 10 to 50. A higher score indicates more positive attitude for constipation improvement and prevention of a participant.
The change of parents' behavior intention towards constipation related issues between 0-week and 4-week
The research tool used in this study is a self-compiled scale of behavior intention in the questionnaire. There are 4 items in the scale. Likert 5-point scale is used for each item, with 1 representing strongly disagree and 5 strongly agree. Thus the score of this scale ranges from 4 to 20. A higher score indicates more stronger behavioral intentions for constipation improvement and prevention of a participant.

Secondary Outcome Measures

The numbers of changing constipation status between 0-week and 4-week
The numbers of changing constipation status from yes to no and from no to yes between 0-week and 4-week will be recorded and compared.
The numbers of changing constipation status between 0-week and 8-week
The numbers of changing constipation status from yes to no and from no to yes between 0-week and 8-week will be recorded and compared.
The incidence rates of constipation at 4-week
Regarding the students without constipation at the baseline (0-week) in the two groups, the incidence rates of constipation in the two groups will be compared after the intervention (4-week).
The incidence rates of constipation at 8-week
Regarding the students without constipation at the baseline (0-week) in the two groups, the incidence rates of constipation in the two groups will be compared at the follow-up time-point (8-week).
The proportions of improved students at 4-week
Regarding the students with constipation at the baseline (0-week) in the two groups, the proportions of students with improved status in the two groups will be compared after the intervention (4-week). Students with constipation at the baseline and becoming free of constipation will be considered "improved".
The proportions of improved students at 8-week
Regarding the students with constipation at the baseline (0-week) in the two groups, the proportions of students with improved status in the two groups will be compared at the follow-up time-point (8-week). Students with constipation at the baseline and becoming free of constipation will be considered "improved".

Full Information

First Posted
October 11, 2020
Last Updated
July 28, 2022
Sponsor
Asia University
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1. Study Identification

Unique Protocol Identification Number
NCT04590846
Brief Title
A Caregiver-mediated Health Educational Intervention to Improve Constipation Status of Primary School Children
Official Title
The Effectiveness of a Caregiver-mediated Health Educational Intervention on Improving Constipation Among Primary School Children and the Knowledge and Attitude Toward Constipation Among Their Caregivers
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
October 7, 2020 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Asia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The research adopts caregiver-mediated health educational intervention to Improve constipation status of primary school children. It is a quasi-experimental design study, which will enroll students in the 3rd to 6th grades of two primary schools and their parents in Yunlin County. There will be 200 children in the experimental group and 200 in the control group. Parents in the experimental group will receive health educational leaflets every week and no intervention will be given to the control group. Both the experimental and control groups students will be asked to fill up a questionnaire at the before and after the intervention with a total of 8 weeks. The study can provide the understanding of the current status of constipation in primary school children, parents' awareness and attitudes on constipation-related issues.
Detailed Description
Background and Purposes: Constipation among children is a global health issue. It can distribute a significant impact on medical, social, and economic dimensions, and can delay children's growth. Without proper treatments on constipation, it would reduce the cure rate and increase recurrence rate. Early diagnosis can improve the prognosis of functional constipation. Only a few studies of children constipation are available in the literature, so it is critical to investigate the topic of constipation among children. Methods: This is a quasi-experimental design study, which will enroll students in the 3rd to 6th grades of two primary schools and their parents in Yunlin. There will be 200 children in the experimental group and 200 in the control group; a total of 400 students and their parents. Parents in the experimental group will receive health educational leaflets every week and students will have to record the situation of defecation once a week. No intervention will be given to the control group. The 4-weeks intervention is scheduled to be from September to November 2020, with a total of 8 weeks. Both the experimental and control groups will be asked to fill up a questionnaire at the before and after the intervention. The questionnaire includes the defecation and constipation situation of children, physical activity, dietary behavior, life pressure, and parents' knowledge and attitude toward constipation. Both groups of children have to fill out the Stool diary record sheet, including the intervention period and the follow-up period for a total of 8 weeks Children with the first and second types of the Bristol Stool Scale will be defined as constipation. Expected results: The study can provide the understanding of the current status of constipation in primary school children, parents' awareness and attitudes on constipation-related issues. Besides, through the study, a simple and feasible health educational program for parents of primary school children will be proposed, and the efficacy of the program will be evaluated.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Constipation
Keywords
constipation, Bristol Stool Scale, health educational intervention

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This is a quasi-experimental design study, which will enroll students in the 3rd to 6th grades of two primary schools and their parents in Yunlin. There will be 200 children in the experimental group and 200 in the control group; with a total of 400 students and their parents. Parents in the experimental group will receive health educational leaflets every week. No intervention will be given to the control group. The 4-weeks intervention is scheduled to be from September to November 2020. Both the experimental and control groups will be asked to fill up a questionnaire at the before and after the intervention. The questionnaire includes the defecation and constipation situation of children, physical activity, dietary behavior, life pressure, and parents' knowledge and attitude toward constipation. Both groups of children have to fill out the Stool diary record sheet once a week, including the intervention period and the follow-up period for a total of 8 weeks.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
173 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Constipation Health Education
Arm Type
Experimental
Arm Description
Health education leaflets are distributed once a week, and students are asked to bring it back to their parents to read. The activity of "seeing leaflets, accumulating points, and redeeming prizes" is adopted. a reply slip is designed in the weekly health education content, containing 3-5 test questions. Parents need to complete the answers and sign after reading the health education content. Those who have a high degree of correctness and fully paid in within 4 weeks will receive additional points. Students are required to keep a " Stool diary record sheet " every day, and it will be posted in the contact book. Children who have confirmed records and turned in will get 10 points a week, and those who turned in all 8 weeks without random answers can get extra points. The points of the parent health education receipt and the points of the children will be combined and calculated, and the weight will be set according to the total number of points for the draw.
Arm Title
General Health Course
Arm Type
Active Comparator
Arm Description
In order to correctly evaluate the effectiveness of health education intervention, only the parents of the experimental group will receive the health education leaflet during the intervention period. However, after the end of the trial, an electronic file of parental health education in the control group will be provided. Students are required to keep a " Stool diary record sheet " every day, and it will be posted in the contact book. Children who have confirmed records and turned in will get 10 points a week, and those who turned in all 8 weeks without random answers can get extra points. After the children's points are counted, a lottery will be drawn based on the total number of points. Since the experimental group and the control group have different benchmarks for points, the lottery will be drawn separately from each school. During the lottery process, the time will be announced in advance, and the number will be randomly selected by the computer in a live broadcast method.
Intervention Type
Behavioral
Intervention Name(s)
Constipation Health Education Intervention Course
Intervention Description
The 4-weeks health education includes three dimensions. The first is "Causes and Hazards of Constipation". The second is "Constipation Symptoms and Criteria". The third is "Constipation Treatment Strategies and Prevention". Health education leaflets with 3 to 5 test questions in the weekly are distributed once a week, students will bring them back to parents, and parents need to complete the answers and sign after reading them.
Intervention Type
Behavioral
Intervention Name(s)
General Health Course
Intervention Description
General courses about health issues according to the curriculum of each primary school.
Primary Outcome Measure Information:
Title
The change of parents' knowledge towards constipation related issues between 0-week and 4-week
Description
The research tool used in this study is a self-compiled scale of knowledge in the questionnaire. There are 15 items in the scale. For each item, the scoring is 1 or 0 depending on whether a participant's answer is correct or incorrect. Thus the score of this scale ranges from 0 to 15. The higher the score, the better the participant's knowledge of constipation.
Time Frame
0-week, 4-week
Title
The change of parents' attitude towards constipation related issues between 0-week and 4-week
Description
The research tool used in this study is a self-compiled scale of attitude in the questionnaire. There are 10 items in the scale. Likert 5-point scale is used for each item, with 1 representing strongly disagree and 5 strongly agree. Thus the score of this scale ranges from 10 to 50. A higher score indicates more positive attitude for constipation improvement and prevention of a participant.
Time Frame
0-week, 4-week
Title
The change of parents' behavior intention towards constipation related issues between 0-week and 4-week
Description
The research tool used in this study is a self-compiled scale of behavior intention in the questionnaire. There are 4 items in the scale. Likert 5-point scale is used for each item, with 1 representing strongly disagree and 5 strongly agree. Thus the score of this scale ranges from 4 to 20. A higher score indicates more stronger behavioral intentions for constipation improvement and prevention of a participant.
Time Frame
0-week, 4-week
Secondary Outcome Measure Information:
Title
The numbers of changing constipation status between 0-week and 4-week
Description
The numbers of changing constipation status from yes to no and from no to yes between 0-week and 4-week will be recorded and compared.
Time Frame
0-week, 4-week
Title
The numbers of changing constipation status between 0-week and 8-week
Description
The numbers of changing constipation status from yes to no and from no to yes between 0-week and 8-week will be recorded and compared.
Time Frame
0-week, 8-week
Title
The incidence rates of constipation at 4-week
Description
Regarding the students without constipation at the baseline (0-week) in the two groups, the incidence rates of constipation in the two groups will be compared after the intervention (4-week).
Time Frame
4-week
Title
The incidence rates of constipation at 8-week
Description
Regarding the students without constipation at the baseline (0-week) in the two groups, the incidence rates of constipation in the two groups will be compared at the follow-up time-point (8-week).
Time Frame
8-week
Title
The proportions of improved students at 4-week
Description
Regarding the students with constipation at the baseline (0-week) in the two groups, the proportions of students with improved status in the two groups will be compared after the intervention (4-week). Students with constipation at the baseline and becoming free of constipation will be considered "improved".
Time Frame
4-week
Title
The proportions of improved students at 8-week
Description
Regarding the students with constipation at the baseline (0-week) in the two groups, the proportions of students with improved status in the two groups will be compared at the follow-up time-point (8-week). Students with constipation at the baseline and becoming free of constipation will be considered "improved".
Time Frame
8-week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Children with grades 3~6 in general classes of primary schools and their primary caregivers Exclusion Criteria: (1) Students who have mild or more server mental disabilities. (2) Suspected children with mild cognitive impairment who are receiving resource class services. (3) Due to congenital structure, endocrine, small intestinal nerve or muscle abnormalities, abdominal muscle tissue, connective tissue abnormalities, neurological abnormalities, such as irritable bowel syndrome, Hirschsprung disease, milk allergy (lactose intolerance), lupus erythematosus School children in other situations. (4) Children with gastrointestinal-related diseases caused by acquired factors such as heavy metals, vitamin D poisoning, drugs, etc. (5) School children with intestinal paralysis or slow transmission problems, such as hypothyroidism, hypokalemia, and anal sphincter damage.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jia-Zhen Li, MS
Organizational Affiliation
Asia University
Official's Role
Study Director
Facility Information:
Facility Name
Yunlin County Shuicanlin Elementary School
City
Yuanlin
ZIP/Postal Code
65241
Country
Taiwan
Facility Name
Raoping Elementary School
City
Yuanlin
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30400292
Citation
Axelrod CH, Saps M. The Role of Fiber in the Treatment of Functional Gastrointestinal Disorders in Children. Nutrients. 2018 Nov 3;10(11):1650. doi: 10.3390/nu10111650.
Results Reference
background
PubMed Identifier
21354081
Citation
Wu TC, Chen LK, Pan WH, Tang RB, Hwang SJ, Wu L, Eugene James F, Chen PH. Constipation in Taiwan elementary school students: a nationwide survey. J Chin Med Assoc. 2011 Feb;74(2):57-61. doi: 10.1016/j.jcma.2011.01.012.
Results Reference
background
PubMed Identifier
30146529
Citation
Yamada M, Sekine M, Tatsuse T. Psychological Stress, Family Environment, and Constipation in Japanese Children: The Toyama Birth Cohort Study. J Epidemiol. 2019 Jun 5;29(6):220-226. doi: 10.2188/jea.JE20180016. Epub 2018 Aug 25.
Results Reference
background
PubMed Identifier
28049271
Citation
Asakura K, Masayasu S, Sasaki S. Dietary intake, physical activity, and time management are associated with constipation in preschool children in Japan. Asia Pac J Clin Nutr. 2017 Jan;26(1):118-129. doi: 10.6133/apjcn.112015.02.
Results Reference
result

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A Caregiver-mediated Health Educational Intervention to Improve Constipation Status of Primary School Children

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